etac 78271 Hi Loo with Brackets User Manual

: September 4, 2024
: Etac

Table of Contents

etac 78271 Hi Loo with Brackets
Introduction
Device Description
Maintenance
CONTACT
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etac 78271 Hi Loo with Brackets

Introduction

Thank you for choosing an Etac product.
In order to avoid damage during assembly, handling and use, it is important to read this manual and save it for future reference. You can also find it at www.etac.com. You can select your language via the “International” and “Local websites” link. Here you will also find other product documentation, such as prescriber information, pre-purchase guide, and reconditioning instructions.
In the manual, the user is the person sitting in the chair. The carer is the person helping the user.

Device Description

Hi-Loo with brackets is a raised toilet seat, available in two different heights.
It is mounted on the toilet with brackets.

Intended purpose
Hi-Loo with brackets (hereafter also referred to as ”the device” or ”the product”), is a medical device intended for alleviation of or compensation for a functional impairment due to an injury or disability. The device is designed to facilitate access to the toilet for people with restricted functional ability. The raised seat and/or arm supports? intend to provide stability and support when sitting down and standing up before and after performing toilet needs.

Intended user group

The user group for the device is based on the individual’s functional ability and not on a specific diagnosis, health condition or age.
It is intended for individuals with a height of 146 cm or more, or a mass of 40 kg or more.
Secondary users of the device are caregivers providing assistance and clinicians/technicians who set up the device.

Intended environment

The device is intended for indoor use at home environments or institutions and is suitable for use in bathrooms, but not swimming pools or similar corrosive environments.

Intended application

The device is intended for short-term and long-term use and can be applied several times per day.
The device is intended to be used in contact with intact skin.
The device is intended for refurbishment and reuse.

Expected service life

The expected service life is 10 years.
For complete information regarding the service life of the device, see www.etac.com.

Indications

Indication for use is disability, including, but not limited to, an individual with fluctuating balance issues, physiological and/or functional impairment, and/or a history of falls.

Contraindications

There are no known contraindications.

Warnings

Warnings describing a risk element for a specific action or setting of the device can be found in the relevant section.
A defective device must not be used.
Ignoring installation or assembly instructions may result in injury.
Do not stand on the device

Declaration of conformity

The device meets the requirements of the Medical Device Regulation (EU) 2017/745.
The device is tested and meets the requirements of the EN ISO 10993-1, SS EN 12182.

Pre-purchase information

Pre-purchase information can be found at www.etac.com.

Adverse event

In case of an adverse event occurs concerning the use of the device, it should be reported to your local dealer and the national competent authority promptly.
The local dealer will forward information to the manufacturer.

Customization
is everything that goes beyond the manual’s instructions and settings. Devices specially adapted by the customer must not retain Etac’s CE marking. Etac’s warranty expires. If there is any uncertainty regarding the execution of the customization, consult Etac. A device coupled with another device may not retain either device’s CE mark unless combination agreements exist. Contact Etac for current information.

Device description

Seat raiser
Lid
Brackets

Symbols

Symbols in the manual and on the device:

1. Warning, precaution or limitation.
2. Useful advice and tips.
3. Material for recycling.
4. Maximum user weight (see technical data)
5-6. Cleaning (see maintenance)
7. Product weight

Explanation item no label

Product name
Product Description
Serial number
Item number
Date of manufacture
Barcode acc. to GS1-128 GTIN-14 and serial number*

The device’s date of manufacture can be read from the barcode on the device. The number 11 is shown below the barcode in brackets. The number combination after these brackets is the date of manufacture.

Technical data

Mounting and use

Undo the four fixing screws. The screws should be loosened only. Do not remove it completely!
Move the four brackets towards the outside of the seat. Tighten the screws so that it still will be possible to turn the brackets one more click.
Place the Hi-Loo on the toilet bowl and adjust it until there is contact at the front of the bowl.
Turn the rear and front brackets at the side towards the bowl.
Slowly lift the Hi-Loo away from the bowl.
Turn all four brackets one click inwards.
Now tighten the screws. Important: The brackets must remain in position!
Attach the Hi-Loo to the bowl, and front brackets first. Then use downward pressure to secure the rest of the Hi-Loo to the bowl. Check it is securely attached.

Maintenance

Clean the device with a solvent-free detergent which has a pH of 5-9, or with a 70% disinfectant solution. Can be decontaminated at max.
85°C if so required.
Constituent materials are corrosion-resistant.
5-year guarantee against material and manufacturing defects. For terms and conditions, see www.etac.com.

Storage
The device should be stored indoors in a dry place at a temperature above 5°C. If the device has been stored for a long time (more than four months), its function must be checked by an expert before use.

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